INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER— 510(k) K970089

Substantially Equivalent

Innovasive Devices, Inc.

FDA 510(k) clearance K970089 for INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER, Substantially Equivalent on 1997-03-25. Applicant: Innovasive Devices, Inc..

Clearance details

Applicant: Innovasive Devices, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1997-01-10
Decision date: 1997-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.